Background
Aims of the study
Methods
Study design and population
Clinical trial procedures
Assessment
Biometric measures
Clinical measures
Biochemical measures
Statistical analyses
Results
Placebo group (n = 30) | Vitamin D plus probiotic group (n = 30) | P1 | |
---|---|---|---|
Age (y) | 43.2 ± 6.0 | 44.8 ± 8.3 | 0.41 |
Gender | |||
Female | 2 (6.7) | 2 (6.7) | > 0.99† |
Male | 28 (93.3) | 28 (93.3) | |
Height (m) | 168.6 ± 7.5 | 170.6 ± 6.0 | 0.24 |
Weight at study baseline (kg) | 69.5 ± 10.7 | 67.2 ± 9.0 | 0.38 |
Weight at end-of-trial (kg) | 69.5 ± 10.5 | 67.5 ± 8.7 | 0.42 |
Body weight change (kg) | 0.04 ± 0.7 | 0.2 ± 1.2 | 0.43 |
BMI at study baseline (kg/m2) | 24.5 ± 3.7 | 23.1 ± 2.8 | 0.11 |
BMI at end-of-trial (kg/m2) | 24.5 ± 3.7 | 23.2 ± 2.7 | 0.12 |
BMI change (kg/m2) | 0.01 ± 0.2 | 0.1 ± 0.4 | 0.46 |
Placebo group (n = 30) | Vitamin D plus probiotic group (n = 30) | P2 | |
---|---|---|---|
Energy (kcal/d) | 2540 ± 184 | 2488 ± 147 | 0.23 |
Carbohydrates (g/d) | 347.9 ± 42.1 | 337.9 ± 43.2 | 0.36 |
Protein (g/d) | 89.5 ± 12.9 | 85.7 ± 11.2 | 0.23 |
Fat (g/d) | 92.6 ± 13.4 | 92.2 ± 12.2 | 0.91 |
SFAs (g/d) | 26.4 ± 5.6 | 26.3 ± 5.8 | 0.85 |
PUFAs (g/d) | 30.0 ± 8.4 | 28.9 ± 6.9 | 0.61 |
MUFAs (g/d) | 25.0 ± 5.6 | 24.4 ± 5.8 | 0.68 |
Cholesterol (mg/d) | 188.6 ± 97.0 | 222.6 ± 119.7 | 0.18 |
TDF (g/d) | 20.7 ± 5.2 | 18.9 ± 4.8 | 0.18 |
Magnesium (mg/d) | 325.1 ± 88.3 | 295.8 ± 69.7 | 0.15 |
Zinc (mg/d) | 11.1 ± 3.0 | 10.4 ± 2.8 | 0.34 |
Manganese (mg/d) | 2.4 ± 0.8 | 2.3 ± 0.6 | 0.44 |
Calcium (mg/d) | 1203.1 ± 161.9 | 1145.6 ± 231.3 | 0.27 |
Vitamin D (μg/d) | 2.8 ± 0.7 | 2.6 ± 0.5 | 0.24 |
Placebo group (n = 30) | Vitamin D plus probiotic group (n = 30) | P1 | |||||
---|---|---|---|---|---|---|---|
Baseline | End-of-trial | Change | Baseline | End-of-trial | Change | ||
PANSS subscales | |||||||
Negative | 29.1 ± 4.7 | 27.0 ± 3.8 | −2.1 ± 3.7 | 27.8 ± 3.5 | 23.9 ± 5.0 | −3.8 ± 4.1 | 0.08 |
Positive | 19.4 ± 4.9 | 19.3 ± 5.3 | −0.1 ± 2.8 | 22.8 ± 4.7 | 22.3 ± 4.8 | −0.5 ± 3.8 | 0.64 |
General | 38.9 ± 10.8 | 39.2 ± 9.5 | 0.3 ± 3.9 | 34.8 ± 6.4 | 31.7 ± 5.7 | −3.1 ± 4.7 | 0.004 |
Total | 87.5 ± 15.5 | 85.5 ± 14.1 | −1.9 ± 7.5 | 85.4 ± 10.3 | 78.0 ± 11.3 | −7.4 ± 8.7 | 0.01 |
BPRS | 68.1 ± 9.7 | 68.5 ± 7.7 | 0.3 ± 4.9 | 58.5 ± 10.1 | 58.5 ± 10.2 | 0.0 ± 12.3 | 0.89 |
25-OH-vitamin D (ng/mL) | 13.7 ± 3.2 | 13.9 ± 3.3 | 0.2 ± 0.5 | 15.0 ± 4.1 | 24.2 ± 5.3 | 9.1 ± 4.1 | < 0.001 |
TAC (mmol/L) | 1012.5 ± 208.6 | 991.7 ± 189.0 | −20.7 ± 53.3 | 1014.1 ± 143.3 | 1065.3 ± 142.0 | 51.1 ± 129.7 | 0.007 |
GSH (μmol/L) | 591.9 ± 103.2 | 627.3 ± 106.5 | 35.3 ± 93.8 | 681.3 ± 106.5 | 770.2 ± 129.3 | 88.9 ± 128.0 | 0.07 |
MDA (μmol/L) | 2.5 ± 0.8 | 2.7 ± 0.7 | 0.2 ± 0.4 | 2.5 ± 0.9 | 2.2 ± 0.5 | −0.3 ± 0.9 | 0.01 |
hs-CRP (mg/L) | 4.6 ± 1.5 | 4.3 ± 1.7 | −0.3 ± 0.8 | 4.3 ± 2.7 | 2.0 ± 1.5 | −2.3 ± 3.0 | 0.001 |
NO (μmol/L) | 37.8 ± 2.3 | 38.6 ± 2.7 | 0.9 ± 2.0 | 42.2 ± 4.0 | 42.6 ± 5.3 | 0.4 ± 3.0 | 0.43 |
FPG (mg/dL) | 93.2 ± 9.4 | 93.0 ± 8.7 | −0.2 ± 9.9 | 95.0 ± 10.5 | 88.0 ± 11.2 | −7.0 ± 9.9 | 0.01 |
Insulin (μIU/mL) | 12.1 ± 2.0 | 12.5 ± 2.7 | 0.4 ± 2.0 | 12.5 ± 3.7 | 9.8 ± 3.7 | −2.7 ± 2.3 | < 0.001 |
HOMA-IR | 2.8 ± 0.5 | 2.9 ± 0.7 | 0.1 ± 0.7 | 2.9 ± 0.9 | 2.1 ± 0.8 | −0.8 ± 0.7 | < 0.001 |
QUICKI | 0.32 ± 0.009 | 0.32 ± 0.01 | 0.0003 ± 0.01 | 0.32 ± 0.02 | 0.34 ± 0.02 | 0.02 ± 0.01 | < 0.001 |
Triglycerides (mg/dL) | 154.9 ± 62.2 | 165.0 ± 62.2 | 10.1 ± 30.8 | 142.6 ± 59.9 | 134.9 ± 49.7 | −7.8 ± 25.2 | 0.01 |
VLDL-cholesterol (mg/dL) | 31.0 ± 12.4 | 33.0 ± 12.4 | 2.0 ± 6.1 | 28.5 ± 11.9 | 27.0 ± 9.9 | −1.5 ± 5.1 | 0.01 |
Total cholesterol (mg/dL) | 172.6 ± 40.2 | 178.5 ± 35.8 | 5.9 ± 19.5 | 166.7 ± 35.9 | 161.8 ± 36.7 | −4.9 ± 15.0 | 0.01 |
LDL-cholesterol (mg/dL) | 101.2 ± 35.1 | 106.2 ± 32.5 | 5.0 ± 15.8 | 99.7 ± 28.2 | 96.6 ± 31.1 | −3.0 ± 13.9 | 0.04 |
HDL-cholesterol (mg/dL) | 40.4 ± 6.0 | 39.3 ± 6.3 | −1.2 ± 6.3 | 38.5 ± 7.9 | 38.2 ± 9.2 | −0.3 ± 5.7 | 0.59 |
Total−/HDL-cholesterol ratio | 4.4 ± 1.3 | 4.7 ± 1.2 | 0.3 ± 0.8 | 4.4 ± 1.1 | 4.3 ± 1.2 | −0.1 ± 0.6 | 0.04 |
Placebo group (n = 30) | Vitamin D plus probiotics group (n = 30) | P1 | |
---|---|---|---|
PANSS subscales | |||
Negative | −1.9 ± 0.6 | −4.0 ± 0.6 | 0.03 |
Positive | −0.4 ± 0.6 | −0.2 ± 0.6 | 0.82 |
General | 0.7 ± 0.7 | −3.5 ± 0.7 | < 0.001 |
Total | −1.8 ± 1.4 | −7.5 ± 1.4 | 0.007 |
BPRS | 2.7 ± 1.6 | −2.4 ± 1.6 | 0.03 |
25-OH-vitamin D (ng/mL) | 0.2 ± 0.5 | 9.1 ± 0.5 | < 0.001 |
TAC (mmol/L) | −22.3 ± 17.2 | 52.7 ± 17.2 | 0.004 |
GSH (μmol/L) | 16.6 ± 20.4 | 107.7 ± 20.4 | 0.004 |
MDA (μmol/L) | 0.2 ± 0.1 | −0.3 ± 0.1 | < 0.001 |
hs-CRP (mg/L) | −0.2 ± 0.3 | −2.4 ± 0.3 | < 0.001 |
NO (μmol/L) | 0.8 ± 0.5 | 0.4 ± 0.5 | 0.61 |
FPG (mg/dL) | −0.7 ± 1.6 | −6.5 ± 1.6 | 0.01 |
Insulin (μIU/mL) | 0.5 ± 0.4 | −2.7 ± 0.4 | < 0.001 |
HOMA-IR | 0.1 ± 0.1 | −0.8 ± 0.1 | < 0.001 |
QUICKI | 0.0001 ± 0.003 | 0.01 ± 0.003 | < 0.001 |
Triglycerides (mg/dL) | 11.5 ± 4.9 | −9.1 ± 4.9 | 0.005 |
VLDL-cholesterol (mg/dL) | 2.3 ± 1.0 | −1.8 ± 1.0 | 0.005 |
Total cholesterol (mg/dL) | 6.6 ± 3.1 | −5.6 ± 3.1 | 0.007 |
LDL-cholesterol (mg/dL) | 5.1 ± 2.7 | −3.1 ± 2.7 | 0.04 |
HDL-cholesterol (mg/dL) | −0.6 ± 1.1 | −0.9 ± 1.1 | 0.87 |
Total−/HDL-cholesterol ratio | 0.3 ± 0.1 | −0.04 ± 0.1 | 0.06 |